Orthopedic device for dynamically treating the knee

ABSTRACT

An orthopedic device is arranged for dynamically treating the knee. The device includes a hinge assembly, a frame having an upper cuff and a lower cuff spaced apart from and connected by the hinge assembly, and a dynamic shell connected to the frame and extending along the first side of the brace. An adjustment system is connected to the dynamic shell and includes a tensioning element operatively engaging the shell and the hinge assembly. The adjustment system is arranged to increase and decrease tension in the tensioning element. The dynamic shell is arranged to be drawn toward the frontal plane as the orthopedic device goes from an extension orientation to a flexion orientation.

CROSS-REFERENCE TO RELATED APPLICATIONS

The application is a continuation of U.S. application Ser. No.13/664,827, filed on Oct. 31, 2012, now U.S. Pat. No. 9,125,730, issuedon Sep. 8, 2015, which claims the benefit of U.S. provisionalapplication No. 61/553,341, filed on Oct. 31, 2011.

FIELD OF THE DISCLOSURE

The disclosure relates to an orthopedic device, and more particularly toan orthopedic device for dynamically treating or supporting injuries ofthe knee.

BACKGROUND

Stabilization of the knee joint (femur and tibia) is understood to becreated primarily by four key ligaments: the anterior cruciate ligament(ACL), the posterior cruciate ligament (PCL), the medial collateralligament (MCL) and the lateral collateral (LCL) ligament. The ACL ismuch better known, in part because injuries to the ACL are much morecommonly diagnosed. The ACL keeps the tibia from sliding too far forward(anterior) with respect to the femur. Conversely, as depicted in FIG. 1,the PCL prevents the tibia from sliding too far backwards (posterior)with respect to the femur.

PCL tears are graded by severity (I, II or III) of the injury. The gradeis classified by the degree of increased posterior tibia translationcompared with that of the contralateral knee. In general, grading of theinjury corresponds to the following:

Grade 1: The ligament is mildly damaged and has been slightly stretched,but is still able to help keep the knee joint stable. 1-5 mm.

Grade 2: The ligament stretches to the point where it becomes loose.This is often referred to as a partial tear of the ligament. 6-10 mm.

Grade 3: This type of injury is most commonly referred to as a completetear of the ligament. The ligament has been torn into two pieces, andthe knee joint is unstable. 10 mm and greater.

As illustrated in FIG. 2, a PCL injury is typically sustained in a fallwhere the tibia is forced posteriorly with respect to the femur. Anothercommon way that this injury occurs is when the knee hits the dash in amotor vehicle accident.

PCL knee injuries often go surgically untreated, and a common form oftreatment is to permit the PCL to heal on its own. When a PCL is torn,the proximal end of the tibia has a tendency to shift posteriorly whichcauses strain on the healing PCL, and results in a healed PCL that islonger than it was prior to injury. As a result, the healed knee mayexperience some slack wherein the proximal end of the tibia shiftsposteriorly after healing, thereby causing a feeling of instability inthe patient, and increasing the risk for further injury.

An orthopedic device, such as a knee brace, that provides support to theback of the upper calf throughout the range of motion may be used toprevent this unwanted shifting. In the post-operative patient (or eventhe recently injured patient, who has not had, or will have, surgery),this may mitigate the lengthening of the PCL during healing, and preventthe shifting problems described above. In the patient having a PCL thathas healed in a lengthened state, the brace may prevent the undesirableshifting described above, giving the patient added feeling of stability,and a decreasing risk of further injury.

Unfortunately due to poor diagnostic methods, there is uncertainty as tothe annual volume of PCL tears (estimated between 3% and 20% of allligament injuries). PCL injuries have historically been considered tohave benign clinical consequence. Thus if the PCL tear had beendiagnosed, it would often go untreated since it resides outside thejoint capsule and has the ability to heal itself. Unfortunately, whenleft to heal on its own, the PCL typically heals in an elongated length,resulting in joint instability.

Recent estimates place the number of diagnosed PCL tears in the US near25,000 annually. When compared to the number of ACL tears, it places thepercentage at roughly 10%. The question still remains as to how manyknees go undiagnosed. The problem is that if an effort is not made torepair the ligament to maintain its normal length, it will heal in astretched position, creating excessive movement between femoral andtibial joint surfaces; this raises the likelihood of degenerativechanges in the knee leading to osteoarthritis.

PCL reconstruction has been recommended by some clinicians for moresevere injuries, or for PCL injuries combined with other types ofinjuries. Even though some in-vitro biomechanical studies have reportedthat PCL reconstruction can restore knee biomechanics in a model with anisolated injury, the actual surgical management of PCL injuries has beenproblematic; a high number of patients continue to experience residualknee laxity after surgery.

Loads on the PCL have been shown to be dynamic in nature. As the knee ismoved for instance, from a position of full extension to 90 degrees offlexion, the tension on the normal intact PCL ligament increases. Thisincreased tension helps to keep the tibia properly positioned withrespect to the femur. When the PCL is damaged, it is not able to providethis increased tension and may allow the tibia to shift posteriorly. Asmentioned above, if a brace could apply an external force to theposterior calf and in proper measure, it would provide the forcesnecessary to effectively co-locate the femur and tibia. It has beenfound that one possible cause for poor patient outcomes in treatment ofthe acute PCL injury is that the dynamic loads pull the tibiaposteriorly during the healing process, and cause the PCL to heal in anelongated length. This may also result in an increased incidence offuture osteoarthritis.

A properly designed dynamic brace could prevent or mitigate thisoccurrence. If surgery is required, this brace could offer protectionfor the reconstructed PCL throughout its healing process. Since the PCLis extracapsular and has the ability to heal on its own, such a bracemay potentially prevent the need for surgical management. For thepatient who has had a previous PCL injury and experiences joint laxityas no subsequent surgical intervention was undertaken, this brace mayalso provide enhanced stability and confidence. Ultimately, such anorthopedic device could benefit patients with all levels of PCLinjuries. Another cause of poor outcomes is due to the gravity effect.As the patient lays supine and lifts the leg with the knee extended, thetibia falls posteriorly. This effect can be a regular occurrence whilethe patient is in the non weight bearing post operative phase where theycan regularly experience this posterior shifting of the tibia simply bylaying in bed.

The posterior shift of the tibia can be detrimental to the healing PCLand cause undue tension leading to a non-anatomical lengthening of theligament. There are many PCL brace options available, however the knownsolutions lack certain critical functional requirements. Therefore, itis proposed herein to provide an orthopedic device in an exemplary formof a PCL brace that meets the certain critical functional requirementsto effectively treat a PCL injury of the knee. The proposed device willbe to help support the functional healing of an acute PCL injury postoperatively or non-operatively. Another purpose is to maintain theproper bony alignment of the femur and tibia for the patient with poorlyhealed/elongated PCL. Thus, the proposed device would be appropriate forall new PCL injuries and all those patients who never received surgeryto preserve PCL length.

SUMMARY

In accordance with various orthopedic device embodiments describedherein, an exemplary PCL brace may be used in at least the followingthree scenarios: (1) Protection of the PCL post operatively during thehealing process (3-6 months), such that once the PCL has been confirmedto be properly healed, the brace would be no longer needed unless thepatient desires a brace for additional stability during activity; (2)protection of the PCL non-operatively whereby the brace provides dynamicstability allowing the PCL to heal under proper tension without surgery;and (3) protection of the PCL for those individuals whose PCL has healedin an elongated position, whereby the brace provides dynamic stabilityof the PCL for activities.

In accordance with an embodiment of the orthopedic device, an orthopedicdevice is a knee brace arranged for dynamically treating a knee. Thebrace has a central axis and a frontal plane parallel to andintersecting the central axis and dividing the brace along first andsecond sides. The brace has a medial-lateral plane dividing the deviceinto medial and lateral sides, which are generally orientedperpendicular to the frontal plane.

The brace includes a hinge assembly, a frame having an upper cuff and alower cuff spaced apart from and connected by the hinge assembly. Adynamic calf shell is connected to the frame and extends along the firstside of the brace. An adjustment system is connected to the dynamic calfshell and includes a tensioning element operatively engaging the dynamiccalf shell and the hinge assembly. The dynamic calf shell is drawnanteriorly, creating an anteriorly directed force on the proximal tibiain the sagittal plane as the orthopedic device goes from an extensionorientation to a flexion orientation. It has been found from thisorientation that as the tensioning element shortens when the kneeflexes, there is a generation of increased calf loads that in turn urgesthe tibia anteriorly to compensate for an impaired PCL.

The brace further comprises a strut segment connecting the lower cuff tothe hinge assembly, and the tensioning element extends along at leastpart of the strut segment, preferably along the second side. In the caseof arranging the brace for treating an impaired PCL, the tensioningelement extends along the anterior side of the strut segment. Thedynamic calf shell is secured to the strut segment and the tensioningelement extends along at least part of the dynamic calf shell, with thedynamic calf shell being located on the distal posterior side of thebrace when configured for treating the PCL.

In accordance with an embodiment, tensioning element has a first endanchored to the hinge assembly. The hinge assembly may include a pair ofrotation axes, with the tensioning element extending between therotation axes. The hinge assembly is preferably located along thefrontal plane when the device is in an extension orientation; thetensioning element crosses the frontal plane within the hinge assembly.Further yet, the hinge assembly may define a pair of rotation axes and amain axis generally perpendicular to the rotation axes. The tensioningelement may extend between the pair of rotation axes and cross the mainaxis.

The hinge assembly may include a hinge cover defining an entry aperturethrough which extends the tensioning element. The entry aperture ispreferably located on the second side of the frontal plane, and therebyon a side of the frontal plane opposite to the dynamic calf shell. Thehinge cover may define a middle opening with the tensioning elementextending into the hinge assembly and anchored at or near the middleopening of the hinge cover.

The adjustment system may include a tightening device arranged forincreasing and decreasing tension in the tensioning element. Accordingone variation, the tightening device is a dial-tensioning devicearranged for preselected and incremental ratcheting rotationaladjustment of the tensioning element. In this variation, the tensioningelement is preferably a cable that can be wound and unwound by thedial-tensioning device. In variations, the tightening device comprisesstraps or other ratcheting means, such as a linear ratchet, or acombination thereof that permits adjusting the tension in the tensioningelement.

The brace may further include an elongate strut segment connecting thelower cuff to the hinge assembly and having a guide element orientingthe tensioning element from a lateral direction substantiallyperpendicular to the strut segment to a longitudinal direction generallyparallel to the strut segment.

Further yet, the brace may include wings extending from the upper cufflocated on the second side of device toward the first side of thedevice. A strap carrying a pad, an insert forming in part a shell orcombination thereof may extend from the upper cuff on opposed medial andlateral sides thereof and over the wings.

According to an embodiment, the first side of the brace is located on aposterior side of the device and the upper and lower cuffs are locatedon the first side of the brace, particularly when the brace isconfigured for treating a PCL. The upper cuff may have a lateral strutextending more proximally than a medial strut, thereby creating a peakat the lateral side of the upper cuff. As noted above, the dynamic calfshell is likewise located on the posterior side. The device furthercomprises upper and lower straps connected to the upper and lower cuffs,respectively, and extending about the second side of the device locatedon an anterior side of the device.

The brace may also include a lower tibia shell located on the secondside of the device. The lower tibia shell may have a semi-rigid andresilient a generally V-shaped insert. The lower tibia shell is arrangedto counteract the dynamic calf shell as the device goes from anextension orientation to a flexion orientation. Moreover, in theorientation as a PCL brace, the lower shell is adapted as a tibial shellsuch that the V-shaped insert prevents sharp pressure points at a tip ofthe anterior leg corresponding to the tibia that may occur with aconventional strap, and more evenly distributes pressure on the lowerleg due to counteracting forces to the dynamic calf shell.

The orthopedic device may be adapted to treat other knee infirmities byswitching the location of the dynamic calf shell, the orientation of thetensioning element, and the location of the cuffs, shells and straps.

In different embodiments, the orthopedic device is arranged a dynamicfemoral shell that counteracts with a dynamic calf shell, in which boththe dynamic femoral and calf shells are secured to one another by theadjustment system. According to one variation, the dynamic femoral shellis located on the anterior side of the frontal plane whereas the dynamiccalf shell is located on the posterior side of the frontal plane.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentdisclosure will become better understood with regard to the followingdescription, appended claims, and accompanying drawings.

FIG. 1 is a schematic view of the posterior cruciate ligament (PCL) incombination with a femur and tibia.

FIG. 2 is a schematic view of a PCL-type injury and a knee during aPCL-type injury.

FIG. 3 is a perspective view of an embodiment of an orthopedic devicefor treating a PCL.

FIG. 4 is a front elevational view of the embodiment of FIG. 3.

FIG. 5 is a rear elevational view of the embodiment of FIG. 3.

FIG. 6 is a side elevational view of the embodiment of FIG. 3 in anextension position.

FIG. 7 is a side elevational view of the embodiment of FIG. 3 in aflexion position.

FIG. 8 is a schematic detailed view showing a hinge assembly andtensioning element of the embodiment of FIG. 3 in an extension positionfrom an upper perspective.

FIG. 9 is a detailed view of a variation of the embodiment of FIG. 3 inan extension position from a lower perspective.

FIG. 10 is a detailed view of a variation of the embodiment of FIG. 3 ina flexion position.

FIG. 11 is an elevational view of the hinge cover for an adjustmentmechanism for a dynamic tensioning system in the embodiment of FIG. 3.

FIG. 12 illustrates examples of combinations of the adjustment systemand the dynamic tensioning system functioning relative to one anotherand the level of force exerted on first and second shells as a leg goesfrom extension into flexion

FIG. 13 is an elevational view of a variation of an adjustment mechanismfor a dynamic tensioning system in the embodiment of FIG. 3.

FIG. 14 is an elevational view of another variation of an adjustmentmechanism for a dynamic tensioning system in the embodiment of FIG. 3.

FIG. 15 is a perspective view of another embodiment of an orthopedicdevice for treating a PCL.

FIG. 16 is a side elevational view of the embodiment of FIG. 15 in anextension position.

FIG. 17 is a front elevational view of the embodiment of FIG. 15 in anextension position.

FIG. 18 is an elevational view of a hinge in the embodiment of FIG. 15.

FIG. 19 is a detail view of a hinge cover taken from an innerperspective in the hinge embodiment of FIG. 18.

FIG. 20 is a detail view of the hinge cover of FIG. 19 taken from anouter perspective.

FIG. 21 is a detailed perspective view of the lower tibia shell in FIG.15.

FIG. 22 is a schematic view showing force exerted on the lower leg bythe tibia shell of FIG. 21.

FIG. 23 is a graph depicting the load versus time as the knee goes fromextension to flexion and so forth.

FIG. 24 is an exemplary view showing the orthopedic device of FIG. 15 inflexion.

It should be noted that the drawing figures are not necessarily drawn toscale, but instead are drawn to provide a better understanding of thecomponents thereof, and are not intended to be limiting in scope, butrather to provide exemplary illustrations. It should further be notedthat the figures illustrate exemplary embodiments of an orthopedicdevice and the components thereof, and in no way limit the structures ororientations of an orthopedic device and components thereof according tothe present disclosure.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS A. Overview

A better understanding of the different embodiments described herein maybe had from the following description read in conjunction with theaccompanying drawings in which like reference characters refer to likeelements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are shown inthe drawings and are described below in detail. It should be understood,however, that there is no intention to limit the disclosure to thespecific embodiments disclosed, but on the contrary, the intention is tocover all modifications, alternative constructions, combinations, andequivalents falling within the spirit and scope of the disclosure.

It will be understood that, unless a term is expressly defined in thispatent to possess a described meaning, there is no intent to limit themeaning of such term, either expressly or indirectly, beyond its plainor ordinary meaning.

B. Environment and Context of Embodiments

Numerous orthopedic device embodiments and components for use therewithare described herein, with particular focus given to devices andcomponents directed to the knee joint and surrounding areas. Theorthopedic device embodiments may serve in protective, preventative orremedial capacities. While the orthopedic device is described within thecontext of a preferred embodiment that is directed to treating theposterior cruciate ligament (PCL), many of the features described hereinmay be extended to orthopedic devices and components that secure otherjoints and body parts, and to other complications of the knee.

The orthopedic device embodiments and components for use therewith maybe dimensioned to accommodate different types, shapes and sizes of humanjoints and appendages. In addition, embodiments may be modified toorient principal forces exerted by strap systems of the embodiments atany desirable location to secure the device onto a leg in order tostabilize the knee.

The knee joint comprises two joints, lateral and medial, between thefemur and tibia, and one arthrodial joint between the patella and femur.The primary movements of the knee comprise flexion, i.e., rearwardrotational movement of the tibia relative to the femur, and extension,i.e., forward rotational movement of the tibia relative to the femur.

For explanatory purposes, each orthopedic device embodiment or componentthereof described herein may be divided into sections which are denotedby general anatomical terms for the human body. Such anatomical termsare provided to distinguish various elements of the device embodimentsfrom one another, but which are not to be considered to limit the scopeof the disclosure.

Each of these terms is used in reference to a human leg, by way ofexample, which is divided in similar sections with a proximal-distalplane generally extending along the meniscus of the knee between thefemur and tibia. The terms “proximal” and “distal” generally refer tolocations of the device that correspond to the location of leg relativeto the point of attachment of the leg to the body. The terms “upper” and“lower” may be used in combination with “proximal” and “distal” toconnote gradations in location of “proximal” and “distal.” The locationat where the device corresponds to the knee joint is used herein togenerally delimit the proximal and distal sections of the device.

The embodiments of the knee device can also be considered to fall within“anterior” and “posterior” sections by an anterior-posterior plane. Theanterior-posterior plane generally corresponds to the coronal or frontalplane of a human leg which lies along the central longitudinal axis of abody. A posterior side or element is therefore located behind thisanterior-posterior plane, whereas an anterior side or element is locatedin front of the anterior-posterior plane.

The terms “inwardly” or “inner” commonly used herein to distinguish theside of the device that may be directed to the posterior side of thedevice and specifically adjacent to the leg of the wearer of the device.Contrariwise, the term “outwardly” or “outer” are used to denote theside of the device that is opposite to the inwardly side.

The terms “medial” and “lateral” are relative terms that are generallyunderstood as indicating location with respect to the midsaggital planeor midline. Therefore, elements that are located near the midline arereferred to as “medial” and those elements that are further from themidline are considered to be “lateral.” The term “central” is used todenote the area along the midline of a joint thereby dividing andsharing regions of the medial and lateral regions.

From these terms, it follows that the anterior section of the device hasthe following quadrants: (I) proximal-medial, (II) distal-medial, (III)distal-lateral, and (IV) proximal-lateral. The posterior section of thedevice has the following quadrants: (V) proximal-medial, (VI)distal-medial, (VII) distal-lateral, and (VIII) proximal-lateral.Structural members and features thereof will fall within one of thequadrants is specifically referenced in relation to such quadrant,either in its entirety or partially.

The device has a center axis X-X when in the extension position which isformed at the intersection of the anterior-posterior plane and themedial-lateral plane.

The terms “rigid” and “flexible” may be used herein to distinguishcharacteristics of portions of the brace. The term “rigid” is intendedto denote that the frame is generally devoid of flexibility. Within thecontext of frame members that are “rigid,” it is intended to indicatethat they may break if bent with sufficient force. On the other hand,the term “flexible” is intended to denote that features are capable ofrepeated bending. The term “resilient” may be used to qualify suchflexible features as generally returning to the initially molded shapewithout permanent deformation.

The anatomical and characteristic terms described herein are notintended to detract from the normal understanding of such terms asreadily understood by one of ordinary skill in the art of orthotics.Moreover, the elements of the embodiments described herein are intendedto embrace embodiments that generally correspond to the aforementionedanatomical sections. In other words, it is understood that the elementsof the device embodiments described herein may deviate from fallingexactly within the confines of the aforementioned anatomical sections.

C. Embodiments of the Orthopedic Device

In accordance with a first embodiment illustrated in FIGS. 3-7, theorthopedic device 10 is arranged in the form of a PCL brace. The brace10 includes an upper or proximal, first cuff 12 and a lower or distal,second cuff 14, each secured to a pair of strut assemblies 19 located onthe lateral and medial sides of the brace. Each strut assembly 19includes an upper or proximal, first strut segment 22 and a lower ordistal, second strut segment 24 each connected by a hinge assembly 20.The first and second cuffs 12, 14 are preferably located and securednear the end portions of the first and second strut segments 22, 24opposite to the hinge assembly 20. In this embodiment, the first andsecond cuffs 12, 14 are retained stationary to the strut assembly 19.

A first upper strap 38 extends about the anterior side of the brace andconnects to the first cuff 12 to effectively form a circumferential loopabout the upper end of the brace. Similarly, a second lower strap 40extends about the posterior side of the brace and connects to the secondcuff 14 to effectively form a circumferential loop about the lower endof the brace.

The brace includes a first, anterior dynamic femoral shell 16 locatedbetween the first cuff 12 and the hinge assembly 20, and a second,posterior dynamic calf shell 18 located between the second cuff 14 andthe hinge assembly 20. The first and second dynamic shells 16, 18 aredynamically secured to an adjustment system 26 that urges the first andsecond dynamic shells 16, 18 toward one another upon regulation of theadjustment system 26.

The first cuff 12 is preferably arranged on the posterior side of thebrace such that it counteracts with the first dynamic shell 16 which islocated on the anterior side of the brace. Likewise, the second cuff 14is preferably arranged on the anterior side of the brace whereas thesecond dynamic shell 18 is located on the posterior side of the brace.The first cuff 12 is preferably spaced apart from the first dynamicshell by a distance 23, as is the second cuff 14 is preferably spacedapart from the second dynamic shell by a distance 25, the exact distancevarying depending on the size of the brace and the length of a wearer'sleg.

As illustrated, suitable cuff and shell liners 42 may be included toprovide compressive relief to the wearer when straps and tensioningelements are tensioned over a wearer's leg. The hinge assembly 20 maylikewise include condyle pads 44 which provide cushioning to the lateraland medial sides of the knee. The cuffs and shells may includeventilation features, such as in a series or pattern of openings 46, soas to allow better breathability when the brace is worn against the legof the wearer.

The cuffs and shells may be formed from multiple materials or sectionshaving different rigidity or hardness. For example, the core 48 of eachdynamic shell may have greater rigidity than an edge portion 50 whichmay be formed of a less rigid material. Various combinations and methodsfor forming such multiple material or section cuffs and shells can befound in U.S. Pat. Nos. 7,727,174 and 7,749,183, and U.S. patentapplication publication no. 2009/0076426, each incorporated herein byreference.

The adjustment system 26 includes a tensioning element 29, such as acable, that is secured to and adjusted by a tightening device 28 toadjust the length of the cable 29. In a preferred embodiment, thetightening device 28 is a dial-tensioning device 28 arranged forincremental and preselected adjustment in the tension of the tensioningelement. The dial-tensioning device may be rotated clockwise to decreasethe length of the cable 29 and thereby increase the overall tension ofthe adjustment system 20. To decrease the overall tension of theadjustment system, the dial-tensioning device 28 may be rotatedcounterclockwise to increase the length of the cable 29. Thedial-tensioning device may be provided by BOA Technology Inc. and isalso described in US 2009/0287128, which is incorporated herein byreference and belongs to the assignee of this disclosure. The tighteningdevice is not limited to the example provided above, and may comprisestraps, cables, bracket, hook and loop fastener systems, or ratchetingmeans, such as a linear, ladder or buckle ratchet, or a combinationthereof, that permits adjusting the tension in the tensioning element

The first and second dynamic shells 16, 18 are slidingly and pivotallysecured to the strut assembly 19 along slots formed by the first andsecond dynamic shells 16, 18. As the dial-tensioning device 28 isregulated to adjust the tension in the cable 29, the first and seconddynamic shells 16, 18 are urged toward one another, while sliding alongthe slots, and effectively moving relative to the strut assembly 19. Thedynamic shells are also able to pivot relative to the strut assembliesin order to accommodate flexion of the knee and leg.

The dial-tensioning device 28 is preferably centrally secured to thefrontal or outer surface of the first dynamic shell 16, and the cable 29extends from both lateral and medial sides of the dial-tensioning device28 to the first strut segments 22. The upper dynamic shell 16 mayinclude upper guide channels 34 that maintain the direction of the cable29 toward the strut segments 22. The cable 29 is received on the firststrut segments 22 by upper guides 30 which in turn direct the cable 29toward the hinge assembly 20. The cable 29 passes through the hingeassembly 20 and extends to lower guides 32 located on the second strutsegments 24 which in turn direct the cable 29 about the second dynamicshell 18 and through a lower guide channel 36 located or formed on thefrontal or outer surface of the second dynamic shell 18.

It will be noted that ends of the cable 29 are preferably retainedwithin the dial-tensioning device 28 and the portion of the cable 29outside the dial-tensioning device 28 extends continuously about thebrace without interruption. Tensioning of the cable 29 by thedial-tensioning device 28 occurs simultaneously across both the firstand second dynamic shells 16, 18. While this is the preferredembodiment, it will be noted that the orthopedic device is not limitedto a single cable or a single dial tensioner, but it is envisioned thatmultiple cables and dial tensioners may be used to urge or move thefirst and second dynamic shells relative to the strut assembly.

FIGS. 8-10 exemplify the cable 29 and hinge assembly 20 from an outerperspective of the brace. In reference to FIG. 8, the guide 30 is shownas having a guide route 54 that directs the cable 29 extending from thefrontal surface of the first dynamic shell 16 along the first strutsegment 22 and into the hinge assembly 20 via one of a series of upperopenings 56 formed in part by a face plate 52 of the hinge assembly 20.FIG. 9 shows the cable 29 exiting the hinge assembly 20 from one of aseries of lower openings 58 formed by the face plate 52. FIG. 10 showsthe travel of the cable 29 relative to the strut assembly 19 when theknee is placed into flexion, and can be contrasted from the extensionposition brace in FIGS. 8 and 9.

FIGS. 11, 13 and 14 show different dynamic tightening device embodimentsof the internal aspects of how the hinge assembly may dynamically engagethe cable. First, in observing FIG. 11, this tightening device relies onthe hinge cover 52 as forming a plurality of fixed channel routes 60,62, 64, 66 extending along elongate channels 68 and opening from thehinge assembly at the upper and lower openings 56, 58. For example, thecable 29 enters at a corresponding one of the upper openings 56, entersthe channel route 60 so as to be retained by the corresponding elongatechannel 68 and departs from the hinge assembly from a correspond one ofthe lower openings 58. The hinge cover 52 includes a cavity 70 which mayreceive the actual hinge mechanism used to secure the first and secondstrut segments to one another and simulate movement of the knee.

The channel routes 60, 62, 64, 66 are located on the anterior side ofthe hinge cover 52, and are offset relative to the hinge centerdemarcated by a longitudinal hinge main axis Y-Y. The relationship ofthe channel routes relative to the hinge center determines the level offorce generated by the adjustment system and hence the level of forceexerted by the first and second dynamic shells on the tibia of thewearer of the brace. The placement of where the cable runs with respectto the hinge center will vary the excursion of the cable and thus imparta dynamic force it can impart on the leg.

It follows that the farther in front of the hinge axis, the greater theexcursion of the cable and thus the greater the dynamic force it canexert on the second dynamic shell and the first dynamic shellsimultaneously, thus creating a higher PCL stabilizing force for thesame range of motion. The dynamic force achieved by placement of thecable relative to the hinge center is separate and distinct from merelytensioning the cable by the dial tensioner.

As shown in FIG. 7, in comparison to FIG. 6, the dynamic shells may betightened by the adjustment system, when the brace is in eitherextension or flexion, as evidenced by force arrows A, B. When the kneegoes into flexion, rotational forces or dynamic forces arise by thedynamic tightening device, so that if both the adjustment system istensioned and the dynamic tightening device is relied upon by mountingthe cable forward the hinge center, forces C, D in addition to forces A,B push the tibia forward to dynamically assist knee laxity and the PCLin general.

FIG. 12 illustrates examples of combinations of the adjustment systemand the dynamic tensioning system function relative to one another andthe level of force exerted on first and second dynamic shells as a leggoes from extension into flexion. In the first arrangement of Example 1,the cable is placed in a channel route farthest from the hinge center,and the adjustment system is tensioned. This combination results in highdynamic force exerted on the tibia in connection to the femur by thefirst and second dynamic shells. However, the starting tension is alsothe highest as there is already an existing force on the leg due to thetension in the adjustment system before the leg goes into flexion.

Turning to Example 2, the cable is placed in a channel route againfarthest from the hinge center; however the adjustment system is nottensioned and does not effectively exert any tension on the leg when theleg is in extension. A high force is again exerted on the leg as the leggoes into flexion however the force is less than in Example 1 due tothere being no tension on the leg due to the adjustment system beforeflexion.

Referring to Example 3, the cable is placed in a channel route closer tothe hinge center, and again the adjustment system is not tensioned anddoes not effectively exert any tension on the leg when the leg is inextension. A lower force than in Example 3 is exerted on the leg.

Lastly, in Example 4, the cable is placed along the hinge center andthere is no initial tension exerted by the adjustment system. From thisconfiguration, there is little or no dynamic tensioning exerted by thedynamic tensioning system as they leg goes into flexion.

When dosing the brace on the leg of a wearer, certain considerations aremade regarding the dosing including the knee laxity, the activity of thewearer, and the size of the wearer's leg and anatomy. The brace may beadapted to permit the practitioner to set the tension on the brace,particularly by the adjustment system, the dynamic tensioning system, orboth, and to assure that the wearer has some visual or audionotification of correct adjustment of the brace.

One option for assuring correct dosage of the brace is to set a seriesof indicia, such as numbers or symbols, on the cable that can be reliedupon to match a certain load that the brace may exert on the wearer fromextension and a range of flexion. Another option is to provide a loadsensor in the cable that indicates through audio or visually whether aload on the knee and leg is too high. Yet another option is to providesensors that track the distance of the cable or the relationship amongthe dynamic shells so that adjustment of the cable or shells does notexceed a certain threshold.

FIG. 13 shows another embodiment of a dynamic tightening device 53having a movable cam element 74 slide mounted on a plate 72. The camelement 74 moves between and is retained from upward or downwardmovement by upper and lower bearings or rivets 76, 78 located along thehinge axis Y-Y between which an arm 80 slides. The cam element mayslidingly engage the bearings, or alternatively the bearings areactually rivets provided irrespective to any motion of the cam element.The plate 72 includes at least one slot 82 permitting sliding movementof the cam element 74 relative to the plate 72. At least one fastener 84locks the cam element 74 in position so as to position a face 86 of thecam element 74 for receiving the cable 29. This embodiment permits amultitude of positions of the cam element and allows for drawing thecable away from the hinge axis, only to be limited by the length of thearm 80.

FIG. 14 shows another embodiment wherein a rotatable cam element 88 ispositioned about the bearing 78. The cam element 88 may be mounted abouteither of the bearings 76, 78 so as to draw the cable 29 away from thehinge center. The cam element 88 includes a face 90 about which thecable extends, and a fastener 92 is used to secure the bearing 78 andcam element 88 in a fixed position.

It will be noted that the device is not limited to an actual hingemechanism for securing the first and strut segments to one another andsimulate movements of the knee. Instead, the embodiments in FIGS. 11, 13and 14 are primarily only directed to means for dynamically engaging thecable to the hinge assembly.

FIGS. 15-17 illustrates another embodiment of the orthopedic deviceaccording to the disclosure in the form of a PCL brace. The embodimentincludes a frame having an upper cuff 112 and a lower cuff 114 spacedapart from and connected by a hinge 120, between the front knee FK andback knee BK, by upper and lower struts 122, 124. Both the upper andlower cuffs 112, 114 are arranged on the posterior side of the device onboth the upper leg UL and lower leg LL, respectively, in part due toease of donning the device, and also in supporting the leg andmaintaining the brace on the leg in view of the adjustment system 118.

The upper cuff 112 has a peak side generally located on the posteriorlateral side and formed in part by a lateral segment 113, which ishigher than a medial segment 117 and linked by a sloping segment 115.The arrangement of the upper cuff is advantageous in that it contributesto medial and lateral stability as the lever or lateral segment 113increases in side. The arrangement also allows for coverage of morefemoral and thigh soft tissue for better distributing pressure over theupper leg UL. The lower height of the medial segment 117 provides for alower profile on the medial side as it is more desired for improvedcomfort between soft tissue for right and left legs, thereby minimizingthe side of the cuff to avoid bumping the medial side of the other leg.

In order to counteract the upper and lower cuffs 112, 114, the braceincludes an upper femoral shell 128 connected to the upper strut 122 bya strap 136 and covered with padding 139, and a lower tibial shell 130including a generally V-shaped insert 152 and is connected to the lowercuff 114 or lower strut 124 by a strap 148 and a bracket 150 such as aD-ring. The lower tibial shell may likewise be covered with padding 131.A padding wrap 135 preferably circumferentially extends around the lowerleg LL and extends between a dynamic calf shell 116 and the lower cuff114. The padding wrap 135 may be adjustable and tightenable over thelower leg, and may be integrally connected between the locationscorresponding to the dynamic shell and the lower cuff.

The brace 110 includes upper wings 132 extending generally from theupper cuff 112 and projecting toward and wrapping about at least aportion of the anterior side of the brace. Padding 137 is provided incombination with the wings 132, and the wings are more rigid andresilient than the padding 137. A strap 145 may extend over the wings132 or connect to the wings so as to extend about the anterior side ofthe brace. Alternatively, the strap 145 may be connected to the padding137 or be formed as part of the padding 137 so as to define a wrap aboutthe upper leg.

The wings are arranged to cover more surface of the upper leg,particularly on the anterior side of the leg than a simple strap andwork to contain soft tissue around the femur, and prevent the strap fromdigging into the soft tissue. In many conventional braces, straps have atendency to submerge or pressed deeply into soft tissue of the thighwhich cause discomfort and may lead to less stable attachment to thethigh. The wings are particularly arranged on at least the medial andlateral sides, and reaching into a portion of the anterior side of thethigh to avoid locations at which conventional straps are prone topressing deeply into the soft tissue.

The adjustment system 118 is arranged on the dynamic calf shell 116,which is generally arranged over the upper and fleshy portion of awearer's posterior calf. The dynamic shell 116 is connected to the lowerstrut 124 by a strap 144, and may be pivotally connected or connected ina fixed orientation relative to the lower strut 124.

The adjustment system 118 includes a tensioning element 126, such as theaforementioned cable in other embodiments described herein. When thebrace is arranged in extension, the cable 126 extends from thetightening device 118 in a generally lateral direction by extendingthrough guides 134 located on the dynamic shell 116, and is redirectedin a generally longitudinal direction by guides 143 located on the lowerstrut 124 to an aperture 138 on a hinge cover 140 of the hinge 120. Theadjustment system may be arranged in accordance with any of the examplesdescribed herein.

The guides 134 may comprise any number of types of guides for routingthe cable 126 to the lower strut 124. It is preferable that the cable126 is arranged laterally relative to the lower strut 124 and receivedby the guide or series of guides 141 located on the lower strut 124. Theguides 134, 141 may comprise tubes, brackets, channels and any othertype of form that will permit the cable to be directed in a straightorientation (in the case of the guides 134) and curved or reorientedorientation (in the case of the guides 141) located on the struts whichessentially direct the cable in a direction perpendicular to the guides134. While the embodiment of FIG. 16 shows the cable 126 as generallyrunning alongside an anterior side of the lower strut 124 as itapproaches the hinge 120, it will be noted that additional guides may beemployed along the lower strut to maintain the cable in thisorientation, or in an alternative orientation.

Referring to FIGS. 18-20, the hinge assembly 120 includes hinge headportions 158, 160 having rotational axes A, B aligned along a verticalor main axis Y-Y of the hinge assembly. The hinge cover 140 includes anentry aperture 138 located along a lower corner on the anterior side ofthe hinge 120 and the main axis through which extends the cable 126. Thecable is anchored at anchor point 156 on the hinge cover 140. The cable126 is arranged to extend between the rotational axes A, B, and at leastover the lower axis B so that as the hinge goes from extension toflexion, the cable 126 is pulled over the lower axis B.

The relationship to the entry aperture and the axis is similar to theembodiments discussed above in connection with the embodiments of FIGS.11, 13 and 14, and the discussion in connection with the graph of FIG.12. In other words, placement of the entry aperture impacts the forcelevel exerted by the dynamic shell due to the length of the tensioningelement.

Taken from the inner side of the hinge cover 140 in FIG. 19, the hingecover 140 includes a channel 166 through which the cable 126 extends toa hole 168 communicating with the exterior side of the hinge cover 140.FIG. 209 shows the cable 126 as having an anchor 156 which fits within aslot 154 formed on the exterior side of the hinge cover so as to retainthe upper end of the cable 126 to the hinge 120.

FIG. 21 depicts the lower tibia shell 130 that is adapted to more evenlydistribute loads on the anterior tibia. The tibia shell 130 includes thesemi-rigid or flexible insert 152 that generally maintains a V-shape.The padding 131 is provided on the rear side of the lower tibia shell130 and is adapted to be placed adjacent to the anterior tibia of thewearer. The strap 133 is intended to extend about the front side of thelower tibia shell 130 and is slidably retained to the lower tibia shell130 by loops 141 which allows for the strap to be adjusted while stablymaintaining the lower tibia shell on the wearer's leg. The strap 133 iscoupled to the lower cuff 114 by a bracket 150.

As schematically shown in FIG. 22, the V-shape of the insert 152 isadvantageous in that is avoids forming a direct pressure point PP on theanterior tibia bone TB, particularly in view of the counteracting forcesdue to the anterior pressure applied by the dynamic shell as the kneegoes into flexion. The pressure point PP on the anterior tip can createundue pressure on the tibia bone TB and therefore harm the wearer. Theshape of the insert 152 and thus the lower tibial shell 130 thereforeforms a greater load bearing LB area on both sides of the pressure pointPP, avoiding the tip of the anterior tibia bone TB, and comfortablyallows the strap 133 to extend about the wearer's fibula bone FB and thetibia bone TB by creating more surface area on the sides of the tibiabone TB.

In referring to FIG. 23, a chart shows the calf loading (anteriorlydirected estimated load on the posterior proximal tibia) and the thighloading (posteriorly directed counter force on the distal anteriorfemur) as the knee goes from extension to flexion and back. The uppercurve in solid line represents the calf and the lower curve representsthe thigh. The loading is plotted against time. Peak loading occurs atpeak flexion, which is limited to approximately 90 degrees, as shown infront knee FK and back knee BK with the brace 110 in flexion in FIG. 24.From the curves, it follows that as the cable shortens when the kneeflexes, there is a generation of increased calf loads that in turn urgesthe tibia anteriorly to compensate for an impaired PCL thereforedynamically treating the knee.

The invention claimed is:
 1. An orthopedic device arranged fordynamically treating a knee, the orthopedic device having a central axisand a frontal plane parallel to and intersecting the central axis anddividing the orthopedic device along first and second sides, theorthopedic device having a medial-lateral plane and dividing theorthopedic device into medial and lateral sides and generally orientedperpendicular to the frontal plane, the orthopedic device comprising: ahinge assembly; a frame comprising an upper cuff and a lower cuff spacedapart from and connected to one another by the hinge assembly; anadjustment system including an elongate tensioning element operativelyengaging the hinge assembly; wherein the adjustment system adjusts intension as the upper cuff moves relative to the lower cuff according toarticulation of the hinge assembly; wherein the hinge assembly includesa hinge cover that the tensioning element engages; and wherein thetensioning element has an end anchored to the hinge cover.
 2. Theorthopedic device of claim 1, wherein the tensioning element is a cable.3. The orthopedic device of claim 1, wherein the tensioning elementextends in a lateral direction between medial and lateral sides of theorthopedic device generally parallel to the frontal plane and redirectedin a generally longitudinal direction by guides located on the frame tothe hinge assembly.
 4. The orthopedic device of claim 1, wherein thehinge cover includes an entry aperture through which the tensioningelement extends.
 5. The orthopedic device of claim 1, wherein the hingecover includes a channel through which the tensioning element extends toa hole communicating with the exterior side of the hinge cover, thetensioning element having an anchor fitting within a slot formed on anexterior side of the hinge cover so as to retain an upper end of thetensioning element to the hinge assembly.
 6. The orthopedic device ofclaim 1, wherein the hinge assembly has first and second rotational axessuch that the tensioning element extends between the first and secondrotational axes so that as the hinge goes from extension to flexion, thetensioning element is pulled over the second axis.
 7. The orthopedicdevice of claim 6, wherein the first axis is located proximate the uppercuff and the second axis is located proximate the lower cuff, with thefirst axis located above the second axis.
 8. The orthopedic device ofclaim 6, wherein the tensioning element is mounted at a location betweenthe first and second axes.
 9. The orthopedic device of claim 1, furthercomprising a shell upon which the adjustment system is located, andconnected medial and lateral sides of the frame by a strap.
 10. Theorthopedic device of claim 9, wherein the tensioning element extendsfrom opposed sides of the shell and extends to first and second hingesbelonging to the hinge assembly and located on lateral and medial sidesof the orthopedic device, respectively.
 11. The orthopedic device ofclaim 9, wherein the shell and the lower cuff are located on the firstside of the brace.
 12. The orthopedic device of claim 11, wherein theupper cuff is located on the first side of the brace.
 13. The orthopedicdevice of claim 12, further comprising first and second straps extendingabout the second side of the orthopedic device and counteracting theshell, and upper and lower cuffs.
 14. The orthopedic device of claim 13,wherein the second strap carries a tibial shell including a V-shapedconfiguration and is pivotally connected to the lower cuff.
 15. Theorthopedic device of claim 1, further comprising a strap carrying atibial shell including a V-shaped configuration arranged for formingpressure outside of an anterior tibia bone, the strap connected to thelower cuff.
 16. A method for dynamically treating a knee with anorthopedic device comprising a hinge assembly, a frame comprising anupper cuff and a lower cuff spaced apart from and connected by the hingeassembly, a shell connected to the frame by an adjustment systemincluding an elongate tensioning element operatively engaging the hingeassembly, the method comprising: placing the shell over the calf of auser; increasing tension in the tensioning element as the hinge assemblyarticulates; obtaining loading of the shell against the calf at peakflexion of the hinge assembly when the upper cuff articulates relativeto the lower cuff.
 17. The method of claim 16, further comprising thestep of adjusting tension in the tensioning element by regulating theadjustment system when the orthopedic device is in extension and priorto flexing the hinge assembly.
 18. An orthopedic device arranged fordynamically treating a knee, the orthopedic device having a central axisand a frontal plane parallel to and intersecting the central axis anddividing the orthopedic device along first and second sides, theorthopedic device having a medial-lateral plane and dividing theorthopedic device into medial and lateral sides and generally orientedperpendicular to the frontal plane, the orthopedic device comprising: ahinge assembly; a frame comprising an upper cuff and a lower cuff spacedapart from and connected to one another by the hinge assembly; anadjustment system including an elongate tensioning element operativelyengaging the hinge assembly; a shell upon which the adjustment system islocated, and connected medial and lateral sides of the frame by a strap;wherein the adjustment system adjusts in tension as the upper cuff movesrelative to the lower cuff according to articulation of the hinge. 19.The orthopedic device of claim 18, wherein the shell and the lower cuffare located on the first side of the brace.